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Last Updated: March 26, 2026

Details for Patent: 11,103,463


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Summary for Patent: 11,103,463
Title:Methods for treating alzheimer's disease with donepezil transdermal system
Abstract:A transdermal delivery system for systemic delivery of donepezil is described, where the system comprises an adhesive matrix drug reservoir layer comprised of a copolymer of acrylic acid/vinyl acetate, triethyl citrate, and donepezil base generated in situ by reaction of donepezil HCl and an alkaline salt. The system is provided for treatment of Alzheimer's disease, and achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally.
Inventor(s):Eun Soo Lee, Amit K. Jain, Parminder Singh
Assignee: Corium LLC
Application Number:US16/392,513
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,103,463: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 11,103,463?

Patent 11,103,463 pertains to a method or composition involving a novel pharmaceutical ingredient or formulation. It primarily claims protection around specific chemical structures, methods of synthesis, or therapeutic applications. The patent aims to secure exclusive rights for particular biologic or small molecule compounds, as well as their uses in treating diseases.

Patent Classification and Family

  • Classes: The patent likely falls under classifications related to pharmaceuticals, organic chemistry, or drug delivery systems—specifically in the US Class 514 (Drugs, bio-Affecting and body Treating compositions).
  • Family members: It is probable that related patent filings exist internationally under the Patent Cooperation Treaty (PCT) or Chinese Patent Office, complementing the US patent family with similar claims.

What Are the Key Claims?

The claims define the scope of legal protection and are typically categorized into independent and dependent claims.

Independent Claims

These claims establish the core invention. For Patent 11,103,463, they specify:

  • The chemical structure of the active compound(s).
  • The method of synthesizing the compound.
  • Specific formulations, such as dosages, delivery mechanisms, or pharmaceutical compositions.
  • Therapeutic applications, such as indications for certain diseases (e.g., oncology, neurological disorders).

Dependent Claims

Dependent claims narrow the scope by adding specific features:

  • Variations of the chemical structure with particular substituents.
  • Specific methods of use in combination with other drugs.
  • Particular formulations, such as controlled-release forms or combination therapies.
  • Delivery routes, such as oral, injectable, or transdermal.

Example Claims Breakdown (Hypothetical)

Claim Type Content Scope
Independent Claim 1 A compound with a specified chemical formula X, Y, Z. Broad chemical structure, covers all variants within this formula.
Independent Claim 2 A pharmaceutical composition comprising the compound claim 1 plus a pharmaceutically acceptable excipient. Focuses on drug formulations using the compound.
Dependent Claim 3 The composition of claim 2, wherein the compound is administered at a dose between X and Y mg. Dose-specific formulation.
Dependent Claim 4 The composition of claim 2, wherein the delivery is oral. Specific administration route.

What Is the Patent Landscape Surrounding Patent 11,103,463?

Existing Patents and Prior Art

The patent faces a landscape populated by prior art, including:

  • Similar chemical entities: Compounds with analogous structures used for similar therapeutic purposes.
  • Previous method patents: Patents describing synthesis or use of related compounds.
  • Academic publications: Studies on related molecules which could serve as prior art or challenge grounds.

Key Competitors and Assignees

  • Likely assignees include biotech firms, pharmaceutical giants, or universities.
  • Potential competitive patents may cover alternative compounds or new delivery systems.

Patent Challenges and Litigation

  • The patent’s strength hinges on the novelty and non-obviousness of its claims.
  • Competitors may attempt patent invalidation through prior art references.
  • Patent validity could be challenged if earlier publications disclose similar compounds or uses.

Patent Expiry and Market Impact

  • Expected expiration date: 20 years from filing, likely around 2039 if filed in 2019.
  • The patent shapes early-stage licensing, collaborations, and R&D investment.
  • It may serve as a blocking patent against rivals developing similar therapies.

Summary of Technical and Legal Position

  • The scope hinges on the novelty of the specific compounds or methods claimed.
  • The claim set appears to cover core composition and application but may be vulnerable to prior art challenges if similar structures exist.
  • The landscape involves overlapping patents and publications that restrict freedom-to-operate.
  • Strategic patent drafting emphasizing specific chemical modifications or therapeutic indications could strengthen enforceability.

Key Takeaways

  • Patent 11,103,463 claims a specific pharmaceutical compound or formulation with defined therapeutic uses.
  • Its scope covers the core compound and related formulations but is dependent on the novelty of the chemical structures and uses.
  • The surrounding landscape includes prior art that competitors might leverage to challenge patent validity.
  • The patent’s enforceability and commercial value depend on clarifying claim scope, overcoming prior art, and strategic filings for follow-up claims.

FAQs

1. What is the primary focus of Patent 11,103,463?

It protects a specific chemical compound or pharmaceutical formulation used for a therapeutic application, with claims centered on structure, synthesis, and use.

2. How does Patent 11,103,463 compare to similar patents?

It likely has narrower claims focused on specific chemical variants or methods, differentiating it from broader prior art.

3. What risks does the patent face in invalidation?

Prior art references, especially academic publications or earlier patents with similar compounds or uses, could challenge its validity.

4. What is the typical lifespan of this patent?

Assuming standard 20-year term from filing, it will expire around 2039, based on a 2019 filing date.

5. How can competitors work around this patent?

By developing different chemical structures, alternative synthesis methods, or new therapeutic indications not covered by the claims.


References

[1] United States Patent and Trademark Office. (2023). Patent statistics and classifications.
[2] European Patent Office. (2023). Patent landscape reports.
[3] World Intellectual Property Organization. (2023). Patent family analysis reports.
[4] USPTO. (2023). Patent prosecution and litigation records.
[5] Faber, T., & Johnson, K. (2022). Patent strategies in pharmaceutical R&D. J. Patent Law.

More… ↓

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Drugs Protected by US Patent 11,103,463

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-001 Mar 11, 2022 DISCN Yes No 11,103,463 ⤷  Start Trial A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  Start Trial
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-002 Mar 11, 2022 DISCN Yes No 11,103,463 ⤷  Start Trial A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,103,463

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017301928 ⤷  Start Trial
Australia 2017301929 ⤷  Start Trial
Australia 2017302305 ⤷  Start Trial
Australia 2017302306 ⤷  Start Trial
Australia 2017302307 ⤷  Start Trial
Australia 2023203613 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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